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Principal Scientist, Qc - Days

4-7 years
Not Disclosed
10 June 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Summary:

Novo Nordisk is hiring a Principal Scientist in Quality Control (QC) at its Bloomington, Indiana facility. This on-site role offers the chance to contribute to cGMP-compliant biotech operations, focusing on routine and complex QC testing, data interpretation, and process improvements within a state-of-the-art pharmaceutical manufacturing environment.


Key Responsibilities:

  • Perform and document cGMP Quality Control testing independently.

  • Operate and troubleshoot moderately complex QC equipment.

  • Author technical documents like SOPs and reports.

  • Prioritize and schedule activities to meet project deadlines.

  • Participate in continuous improvement initiatives.

  • Train others in analytical techniques.

  • Enter and review data in LIMS and laboratory reports.

  • Conduct general lab housekeeping and maintenance per 5S standards.

  • Lead and close out deviation investigations in TrackWise.

  • Drive root cause analysis and CAPA development.

  • Present findings to the Deviation Review Board (DRB).

  • Analyze trends and coordinate quality improvement measures.


Required Skills & Qualifications:

  • Education:

    • Bachelor’s in Science + 7-9 years (4+ years GMP exp.) OR

    • Master’s in Science + 4-6 years (4+ years GMP exp.) OR

    • PhD + 0-4 years (4+ years GMP preferred).

  • Technical Expertise:

    • Strong grasp of analytical chemistry and lab equipment.

    • GMP, GLP, GDP knowledge.

    • Proficient in SOP adherence and documentation.

    • LIMS and TrackWise usage.

    • Familiarity with cleanroom and aseptic procedures.

  • Behavioral Competencies:

    • Excellent communication, multitasking, time management.

    • Detail-oriented with strong problem-solving skills.

    • Ability to lead technical discussions and mentor peers.

    • Positive, adaptable, and team-focused.


Perks & Benefits:

  • Industry-leading salary & annual performance bonus.

  • 14 paid holidays + generous PTO.

  • Comprehensive health, dental, and vision insurance (effective day one).

  • Guaranteed 8% 401(k) contribution + company match.

  • Family-focused benefits: parental leave, family medical leave.

  • Free access to Novo Nordisk-marketed pharmaceuticals.

  • Tuition Assistance Program.

  • Life & Disability insurance.

  • Employee Referral Awards.


Company Description:

Novo Nordisk is a global leader in diabetes care, obesity treatment, and rare disease therapies. At its Bloomington, Indiana site, Novo Nordisk drives innovative biotech manufacturing, offering end-to-end services from formulation to packaging, with a commitment to patient health worldwide.


Work Mode:

On-site — Bloomington, Indiana, USA.


Call-to-Action:

Ready to make an impact on global healthcare with Novo Nordisk? Apply now to become a key contributor in Quality Control and advance your career in the pharmaceutical industry.